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Overview of FSMA Implementation

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The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011.  Although the FSMA is a broad and encompassing legislation, the statute does not addresses all aspects of food law.  The FSMA, for example, pertains to the FDA, but not to the USDA FSIS.  Accordingly, the FSMA impacts food processing  that is overseen by FDA, but does not impact food processing overseen by FSIS (i.e., meat and poultry processing).  Similarly, the FSMA has only SOME impact upon the retail sector of the food industry (e.g., grocery stores, restaurants, cafeterias, and other vendors).  FSMA also impacts some of production agriculture, primarily fresh fruits and vegetables, but has little to no impact on production agriculture input suppliers, such as biotechnology. 

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The following list offers a brief review of the topics addressed in the FSMA; a more detailed description of these FSMA topics can be found by clicking here.

  1. Registration of food facilities
  2. Hazard Analysis and Risk-based Preventive Controls
  3. Administrative Detention
    1. Refined the scope of food for which records can be requested by FDA.
  4. Standards for Produce Safety
  5. Protection against intentional attack
  6. National Agriculture and Food Defense Strategy
  7. Building Domestic Capacity
  8. Sanitary Transportation
  9. Food Allergy
  10. Targeting Inspection
  11. Food Testing Labs
  12. Tracking and Tracing Food
  13. Surveillance of Food-borne Illness
  14. Mandatory Recall
  15. Reportable Food Registry & Grocery Store Notification
  16. Decontamination and Disposal Plan
  17. Improve Training
  18. Foreign Verification
  19. Port Shopping
  20. Smuggled Food
  21. Employee Protection

It will likely take a decade to promulgate regulations and implement each of these topics, but the process is beginning.  As of January 2013, FDA proposed regulations for two of the topics: 1) Hazard Analysis and Risk-based Preventive Controls and 2) Standards for Produce Safety.  The following materials review the statutes for these two topics and the proposed regulations. 

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Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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